Author Interviews, Cancer Research, FDA, Vaccine Studies / 14.08.2019

MedicalResearch.com Interview with: [caption id="attachment_50871" align="alignleft" width="150"]Dr. Graca Dores (left) and Dr. Perez-Vilar (senior author) Dr. Graca Dores (left) and Dr. Perez-Vilar (senior author)[/caption] Dr. Graca Dores MD MPH US Food and Drug Administration Center for Biologics Evaluation and Research Office of Biostatistics and Epidemiology Division of Epidemiology Silver Spring, Maryland Oklahoma City, OK MedicalResearch.com: What is the background for this study? Would you briefly explain what Sipuleucel-T is used for?  Response: Sipuleucel-T was the first therapeutic vaccine approved by the U.S. Food and Drug Administration (FDA) in 2010.  It is indicated for the treatment of asymptomatic or minimally symptomatic, metastatic, castration-resistant prostate cancer (CRPC; prostate cancer that spreads while an individual is on hormone-blocking therapy).  During the preparation of this product, the patient’s cells are collected (leukapheresis), sent for processing to generate a dose of patient-specific vaccine, and then administered intravenously back to the patient.  This process is repeated approximately every two weeks for a total of three doses. Except for the pre-marketing clinical trials that were reviewed during the sipuleucel-T approval process, post-marketing studies that have evaluated the safety profile of sipuleucel-T are scarce. Therefore, we used the FDA’s Adverse Event Reporting System (FAERS) database to summarize the adverse events reported to FDA by industry, medical professionals, and consumers.  We also assessed whether sipuleucel-T and specific adverse events (product-event pairs) were reported more than expected compared to all other drug/biologic-adverse event pairs in the FAERS database.
Accidents & Violence, Author Interviews, Exercise - Fitness, Geriatrics, JAMA / 05.06.2019

MedicalResearch.com Interview with: [caption id="attachment_49471" align="alignleft" width="150"]Teresa Liu-Ambrose, PT, PhDCanada Research Chair (Tier II), Physical Activity, Mobility, and Cognitive NeuroscienceDirector, Aging, Mobility, and Cognitive Neuroscience LaboratoryUniversity of British Columbia Dr. Liu-Ambrose[/caption] Teresa Liu-Ambrose, PT, PhD Canada Research Chair (Tier II), Physical Activity, Mobility, and Cognitive Neuroscience Director, Aging, Mobility, and Cognitive Neuroscience Laboratory University of British Columbia MedicalResearch.com: What is the background for this study? Response:  Falls in older adults are the third-leading cause of chronic disability and the leading cause of hospitalization for adults over age 65. Older adults who experience multiple falls are at increased risk for disability, loss of independence, and even death. How to best prevent falls in this high risk group is not well established. 
Author Interviews, Emory, Heart Disease, JAMA, Pediatrics, Sugar / 19.05.2019

MedicalResearch.com Interview with: Jean A. Welsh, RN, MPH, PhD Departments of Epidemiology and Pediatrics Emory University Wellness Department, Children’s Healthcare of Atlanta Atlanta, Georgia MedicalResearch.com: What is the background for this study? Response: As the evidence has accumulated regarding the health risks associated with sugar-sweetened beverages, I’ve wondered about fruit juices.  Though they have a kind of healthy halo, their main ingredients are the same as sugar-sweetened beverages, sugar and water.  We know that young children drink a lot of fruit juice, and I’ve wondered if older children and adults might switch to drinking more as concern grows about soft drinks and other sugar-sweetened beverages.
Author Interviews, JAMA, Opiods, Primary Care, University of Michigan / 11.05.2019

MedicalResearch.com Interview with: [caption id="attachment_49122" align="alignleft" width="140"]Kao-Ping Chua, M.D., Ph.D.Department of PediatricsSusan B. Meister Child Health Evaluation and Research CenterUniversity of Michigan, Ann Arbor Dr. Kao-Ping Chua[/caption] Kao-Ping Chua, M.D., Ph.D. Department of Pediatrics Susan B. Meister Child Health Evaluation and Research Center University of Michigan, Ann Arbor MedicalResearch.com: What is the background for this study?   Response: Doctor and pharmacy shopping is a high-risk behavior in which patients obtain opioid prescriptions from multiple prescribers and fill them at multiple pharmacies. Because this behavior is associated with a high risk of overdose death, there have been many efforts to help clinicians detect doctor and pharmacy shopping among patients prescribed opioids. For example, 49 states have a prescription drug monitoring program that provides information on patients’ prior controlled substance prescriptions. In contrast, there has been little attention to the possibility that patients prescribed opioids may have family members who are engaged in opioid doctor and pharmacy shopping. Such family members may divert opioids prescribed to patients because of their access to these opioids.
Author Interviews, Opiods, Pain Research / 06.05.2019

MedicalResearch.com Interview with: [caption id="attachment_48970" align="alignleft" width="200"]Jan Klimas, PhD, MScSenior Postdoctoral FellowBC Centre on Substance Use (BCCSU) Vancouver, BC Dr. Klimas[/caption] Jan Klimas, PhD, MSc Senior Postdoctoral Fellow BC Centre on Substance Use (BCCSU) Vancouver, BC MedicalResearch.com: What is the background for this study? What are the main findings?  Response: Some individuals prescribed opioid analgesic medications for pain develop opioid use disorder. So, much research has been conducted to develop strategies to identify patients who can be safely prescribed opioid analgesics. However, this research has not been critically reviewed through rigorous quality assessment. This study therefore sought to identify signs, symptoms & screening tools to identify patients with pain who can be safely prescribed opioids 
Author Interviews, Infections, JAMA / 01.05.2019

MedicalResearch.com Interview with: [caption id="attachment_48954" align="alignleft" width="130"]Nicholas B. DeFelice, PhDDepartment of Environmental Medicine & Public HealthIcahn School of Medicine at Mount SinaiNew York, New York Dr. DeFelice[/caption] Nicholas B. DeFelice, PhD Department of Environmental Medicine & Public Health Icahn School of Medicine at Mount Sinai New York, New York MedicalResearch.com: What is the background for this study? What are the main findings?  Response: Effective allocation of public health resources during an outbreak is complicated and often reactive. Thus, it is important that we develop quantitative tools that can accurately and rapidly forecast the progression of an outbreak and provide decision support. Recently, several advancements have been made in the realm of infectious disease forecasting: it is a field that is growing in exciting directions. However, for these forecasting tools to work in real time, we must understand how the forecasting apparatus and observational network work in real time to ensure they are sufficient to support accurate operational predictions. We previously showed that accurate and reliable forecasts of West Nile virus outbreaks can be made using surveillance data and a mathematical model representing the interactions between birds, mosquitoes and risk of human spillover. This model system was able to retrospectively forecast mosquito infection rates prior to the week of peak mosquito infection, and to forecast accurately the seasonal total number of human West Nile virus cases prior to when the majority of cases were reported. For this study, we were interested in the data flow process and the question of whether appropriate infrastructure is in place to support real time forecasting. If this forecast system were made operational in real time, public health officials would have an evidence-based decision-support tool to help 1) actively target control of infected mosquito populations (i.e., larviciding and adulticiding), 2) alert the public to future periods of elevated West Nile virus spillover transmission risk, and 3) identify when to intensify blood donor screening.
Author Interviews, Biomarkers, Multiple Sclerosis / 30.04.2019

MedicalResearch.com Interview with: [caption id="attachment_48900" align="alignleft" width="140"]Prof. Bernhard Hemmer MD PhDDirector of the Neurology ClinicTechnische Universität München Prof. Hemmer[/caption] Prof. Bernhard Hemmer MD PhD Director of the Neurology Clinic Technische Universität München  MedicalResearch.com: What is the background for this study? What are the main findings?  Response: The course of multiple sclerosis (MS) is still highly unpredictable and reliable markers to predict disability progression are largely missing. We found that patients with a high IgG Index, which means that the produce large amount of IgG within the CNS, have a higher risk of disease worsening during the first 4 years. I would consider patients with an elevated IgG index at a higher risk to run a more severe disease course. The marker could be used together with others to guide treatment decisions after multiple sclerosis diagnosis.
Author Interviews, Cancer Research, Genetic Research, JAMA, Technology / 30.04.2019

MedicalResearch.com Interview with: [caption id="attachment_48863" align="alignleft" width="132"]Steven J.M. Jones, Professor, FRSC, FCAHSCo-Director & Head, BioinformaticsGenome Sciences CentreBritish Columbia Cancer Research CentreVancouver, British Columbia, Canada Dr. Jones[/caption] Steven J.M. Jones, Professor, FRSC, FCAHS Co-Director & Head, Bioinformatics Genome Sciences Centre British Columbia Cancer Research Centre Vancouver, British Columbia, Canada and Jasleen Grewal, BSc.Genome Sciences CentreBritish Columbia Cancer Research CentreVancouver, British Columbia, CanadaJasleen Grewal, BSc. Genome Sciences Centre British Columbia Cancer Research Centre Vancouver, British Columbia, Canada MedicalResearch.com: What is the background for this study? Response: Cancer diagnosis requires manual analysis of tissue appearance, histology, and protein expression. However, there are certain types of cancers, known as cancers of unknown primary, that are difficult to diagnose based purely on their appearance and a small set of proteins. In our precision medicine oncogenomics program, we needed an accurate approach to confirm diagnosis of biopsied samples and determine candidate tumour types for where the primary site of the cancer was uncertain.  We developed a machine learning approach, trained on the gene expression data of over 10,688 individual tumours and healthy tissues, that has been able to achieve this task with high accuracy. Genome sequencing offers a high-resolution view of the biological landscape of cancers. RNA-Seq in particular quantifies how much each gene is expressed in a given sample. In this study, we used the entire transcriptome, spanning 17,688 genes in the human genome, to train a machine learning method for cancer diagnosis. The resultant method, SCOPE, takes in the entire transcriptome and outputs an interpretable confidence score from across a set of 40 different cancer types and 26 healthy tissues. 
Author Interviews, Environmental Risks, Heart Disease, JAMA, Toxin Research / 29.04.2019

MedicalResearch.com Interview with: [caption id="attachment_48834" align="alignleft" width="200"]Monica Lind, PhD, Professor, Environmental toxicologistOccupational and Environmental MedicineUppsala University HospitalVisiting adress: Dag Hammarskjölds väg 60Uppsala Sweden  Dr. Lind[/caption] Monica Lind, PhD, Professor, Environmental toxicologist Occupational and Environmental Medicine Uppsala University Hospital Visiting adress: Dag Hammarskjölds väg 60 Uppsala Sweden MedicalResearch.com: What is the background for this study? Response: Previous studies in workers exposed to very high levels of polychlorinated biphenyls (PCBs) have suggested hazardous health effects. However, circulating PCB levels are detected in almost all indivuduals in industrialized countries, but the health effects of moderately elevated levels as seen in the general population are not well established. We investigated levels of PCBs in around 1,000 individuals, all aged 70 years, randomly chosen from the City of Uppsala, Sweden.
Author Interviews, Environmental Risks, JAMA, Lymphoma, Occupational Health, Toxin Research / 23.04.2019

MedicalResearch.com interview with: Sylvain Lamure, MD, Hematologist, Principal Investigator Pascale Fabbro-Peray, MD, PhD , Epidemiologist, Senior Investigator University of Montpellier, France MedicalResearch.com: What is the background for this study? Response: Occupational exposure to pesticides is a well-documented associated factor for non-Hodgkin lymphoma. The main biological mechanisms of both pesticides and chemotherapy are genotoxicity and reactive oxygen species generation. Cellular adaptation among patients exposed to low doses of genotoxic and oxidative compounds might hinder chemotherapy efficiency in lymphoma patients. T hus, we have investigated the association of occupational exposure with response to immunochemotherapy and survival in the subgroup of diffuse large B cell lymphoma, whose treatment is standardized.
Author Interviews, Diabetes, JAMA, Technology / 18.04.2019

MedicalResearch.com Interview with: [caption id="attachment_48552" align="alignleft" width="150"]Associate Professor Josip CarMD, PhD, DIC, MSc, FFPH, FRCP (Edin)​Associate Professor of Health Services Outcomes Research,​Director, Health Services Outcomes Research Programme and DirectorCentre for Population Health SciencesPrincipal Investigator, Population Health & Living Laboratory Prof. Car[/caption] Associate Professor Josip Car MD, PhD, DIC, MSc, FFPH, FRCP (Edin)​ Associate Professor of Health Services Outcomes Research,​ Director, Health Services Outcomes Research Programme and Director Centre for Population Health Sciences Principal Investigator, Population Health & Living Laboratory  MedicalResearch.com: What is the background for this study? Response: In 2018, almost 8% of people with diabetes who owned a smartphone used a diabetes app to support self-management. Currently, most apps are not regulated by the US Food and Drug Administration (FDA). We downloaded and assessed 371 diabetes self-management apps, to see if they provided evidence-based decision support and patient education. 
Author Interviews, Exercise - Fitness, Gender Differences, Heart Disease, JAMA, Johns Hopkins, Women's Heart Health / 14.04.2019

MedicalResearch.com Interview with: Erin D. Michos, MD, MHS, FACC, FAHA, FASE Associate Professor of Medicine and Epidemiology Associate Director of Preventive Cardiology Ciccarone Center for the Prevention of Heart Disease Johns Hopkins School of Medicine Victor Okunrintemi, MD, MPH Department of Internal Medicine East Carolina University Greenville, North Carolina  MedicalResearch.com: What is the background for this study?   Response: Women are less physically active than men on average, and the lack of regular physical activity has been associated with increased risk of cardiovascular disease and poorer health outcomes. Although recommendations encouraging regular physical activity has been in place for decades, we do not know how much of these recommendations are met, particularly among high risk women with established cardiovascular disease for secondary prevention. This study was therefore designed with the aim of describing the 10-year trends for the proportion of women with cardiovascular disease who do not meet these recommend physical activity levels, overall and by key sociodemographic groups, and the associated cost implications.
Author Interviews, Epilepsy, Genetic Research, JAMA, Pediatrics / 12.04.2019

MedicalResearch.com Interview with: [caption id="attachment_48481" align="alignleft" width="200"]Dr. Ahmad Abou Tayoun, PhDClinical Molecular GeneticistDirector of the Genetics LaboratoryAl Jalila Children’sUnited Arab Emirates Dr. Abou Tayoun[/caption] Dr. Ahmad Abou Tayoun, PhD Clinical Molecular Geneticist Director of the Genetics Laboratory Al Jalila Children’s United Arab Emirates MedicalResearch.com: What is the background for this study?   Response: In this study, we provide data in favor of using an exome-based testing approach, where parental samples can be readily accessible, for early onset epilepsy patients. The exome test includes all coding genes in the human genome. Although we perform exome sequencing on those patients, we demonstrate that a first tier analysis should include targeted interpretation of ~100 genes strongly associated with the disease. This analysis provides diagnoses in ~11% of the patients. Follow up parental testing on a limited number of patients (n=15) that had inconclusive results, revealed de novo (new mutations) variant status, leading to upgrade to positive reports in 7 patients and adding ~5% to the overall diagnostic yield.
ADHD, Author Interviews, JAMA, OBGYNE, Pediatrics, Pharmacology / 08.04.2019

MedicalResearch.com Interview with: [caption id="attachment_48399" align="alignleft" width="128"]Dr. Angela Lupattelli, PhDSchool of PharmacyUniversity of Oslo Dr. Lupattelli[/caption] Dr. Angela Lupattelli, PhD School of Pharmacy University of Oslo MedicalResearch.com: What is the background for this study? What are the main findings?  Response: Between 1-4% of pregnant women take at least once a benzodiazepine and/or a z-hypnotic medication during the course of gestation. These medications are generally used intermittently in pregnancy, mainly for treatment of anxiety disorders and sleeping problems, which are not uncommon conditions among pregnant women. However, data regarding the safety of benzodiazepine and/or a z-hypnotic in pregnancy on child longer-term development are sparse. For instance, studies on child motor skills are only available up to toddler age, and little is known in relation to other child developmental domains. So, there is an urgent need to better understand whether prenatal use of benzodiazepine and/or a z-hypnotic medication may pose detrimental longer-term child risks.
Author Interviews, JAMA, Kidney Disease / 08.04.2019

MedicalResearch.com Interview with: [caption id="attachment_48348" align="alignleft" width="120"]Matthew T James MD, PhDAssistant ProfessorUniversity of Calgary Dr. James[/caption] Matthew T James MD, PhD Assistant Professor University of Calgary  MedicalResearch.com: What is the background for this study? What are the main findings?  Response: The Acute Kidney Disease and Disorders (AKD) criteria from the KDIGO Acute Kidney Injury guidelines identified many patients who do not meet existing criteria for Chronic Kidney Disease or Acute Kidney Injury (AKI), and the majority of AKD events occured in the community rather than hospital setting. This study characterized the frequency and outcome for patients with AKD (without  AKI) as well as AKD with CKD from among over 1.1 million adults  residing in Alberta Canada who received  kidney function testing and were followed for up to 8 years.
Author Interviews, Cost of Health Care, General Medicine, Hospital Readmissions, JAMA, Race/Ethnic Diversity / 02.04.2019

MedicalResearch.com Interview with: [caption id="attachment_48340" align="alignleft" width="142"]Teryl K. Nuckols, MDVice Chair, Clinical ResearchDirector, Division of General Internal MedicineCedars-Sinai Medical Center  Dr. Nuckols[/caption] Teryl K. Nuckols, MD Vice Chair, Clinical Research Director, Division of General Internal Medicine Cedars-Sinai Medical Center  MedicalResearch.com: What is the background for this study?   Response: Healthcare policymakers have long worried that value-based payment programs unfairly penalize hospitals treating many African-American patients, which could worsen health outcomes for this group. For example, policy experts have suspected that the Medicare Hospital Readmission Reduction Program unevenly punishes institutions caring for more vulnerable populations, including racial minorities. They've also feared that hospitals might be incentivized to not give patients the care they need to avoid readmissions. The study Investigators wanted to determine whether death rates following discharges increased among African-American and white patients 65 years and older after the Medicare Hospital Readmission Reduction Program started.
Author Interviews, JAMA, OBGYNE, Pediatrics / 31.03.2019

MedicalResearch.com Interview with: [caption id="attachment_48281" align="alignleft" width="200"]Abhay K Lodha Department of PediatricsAlberta Health Services  Dr. Lodha[/caption] Abhay K Lodha MD, DM, MSc Department of Pediatrics Alberta Health Services   MedicalResearch.com: What is the background for this study? Response: There is no physiological rationale for clamping the umbilical cord immediately after birth. In moderate (32+0 weeks-33+6 weeks) and late preterm infants (34+0 to 36+6), delayed cord clamping reduces the need for blood transfusions, leads to circulatory stability and improves blood pressure. However, the information on the association of delayed cord clamping with outcomes for extremely low gestational age neonates (22-28 weeks of gestation) is limited.
Author Interviews, JAMA, Smoking, Tobacco Research / 29.03.2019

MedicalResearch.com Interview with: Jidong Huang, PhD Associate Professor Department of Health Policy & Behavioral Sciences School of Public Health, Georgia State University Atlanta, GA 30303 MedicalResearch.com: What is the background for this study?   Response: The US tobacco market has been transformed in the past decade by a rapid increase in awareness and use of e-cigarettes among youth and adults. This transformation has been accelerated in recent years by the emergence of new generations of e-cigarettes, such as JUUL e-cigarettes. The exponential growth in e-cigarettes has prompted a renewed interest in the tobacco harm reduction approach, which aims to rapidly curbing the smoking epidemic by encouraging smokers to switch to low risk tobacco products, such as e-cigarettes. There is an ongoing debate about whether the scientific evidence on the health risks of e-cigarettes in comparison with combustible cigarettes has been accurately communicated to the public. Large representative surveys are needed to examine how the public perceives the health risk of e-cigarettes and how their perception change over time.
Author Interviews, Opiods / 25.02.2019

MedicalResearch.com Interview with: [caption id="attachment_47585" align="alignleft" width="200"]Dr-Mathew Vinhhoa Kiang Dr. Kiang[/caption] Mathew Vinhhoa Kiang, PhD Postdoctoral Research Fellow Primary Care and Outcomes Research Stanford University School of Medicine Stanford, California MedicalResearch.com: What is the background for this study? What are the main findings? Response: Nationally, opioid-related mortality has continued to climb for decades and resulted in over 42,000 deaths in 2016 — more than the number of deaths from car accidents or firearms. However, there are substantial differences across states and by opioid type. We sought to systematically describe these differences by examining state-level opioid mortality by opioid type. Deaths from synthetic opioids, such as fentanyl, are rapidly increasing in the eastern half of the US. Specifically, 28 states have synthetic opioid mortality rates that are more than doubling every two years. Twelve of those states already have high levels of synthetic opioid mortality — above 10 deaths per 100,000. Lastly, the opioid epidemic has reached our nation's capital — Washington DC has the fastest rate of increase, more than tripling every year, and a high opioid mortality rate.
Aging, Author Interviews, Exercise - Fitness, JAMA / 25.02.2019

MedicalResearch.com Interview with: [caption id="attachment_47520" align="alignleft" width="142"]Fuzhong Li, Ph.D. Senior Scientist Oregon Research Institute Dr. Li[/caption] Fuzhong Li, Ph.D. Senior Scientist Oregon Research Institute MedicalResearch.com: What is the background for this study? What are the main findings? Response: Injurious falls among community-dwelling older adults are a serious public health and cost-bearing problem worldwide.Exercise has been shown to reduce falls and injurious falls among older adults. However, evidence is limited with regard to the type of exercise interventions that are most effective, without exacerbating the risk in some individuals, in reducing injurious falls. This study addresses this knowledge gap in the field of falls prevention. Findings from this study showed that a six-month Tai Ji Quan program reduced the incidence of injurious falls among frail elderly by 53% compared to a regular (multimodal) exercise intervention. The effect of the Tai Ji Quan intervention was shown to be robust, and still evident at follow-up examinations six months after the study.
Accidents & Violence, Author Interviews, JAMA / 25.02.2019

MedicalResearch.com Interview with: [caption id="attachment_47576" align="alignleft" width="100"]Hannah Decker Hannah Decker[/caption] Hannah Decker MD Candidate, Class of 2019 Emory School of Medicine [caption id="attachment_47661" align="alignleft" width="142"]Jeremiah Schuur, MD, MHS FACEPPhysician-in-chief for emergency medicine at Lifespan and Chair of the department of Emergency Medicine Brown Dr. Jeremiah Schuur[/caption] Jeremiah Schuur, MD, MHS FACEP Physician-in-chief for emergency medicine at Lifespan and Chair of the department of Emergency Medicine Brown MedicalResearch.com: What is the background for this study? What are the main findings?  Response: Firearm injury is a leading cause of injury and death in the United States. Many physician groups advocate for evidence-based policies, such as universal background checks, to reduce this morbidity and mortality. We studied contributions of the 25 largest political action committees (PACs) affiliated with physician professional groups during the 2016 election cycle and found that almost all gave more money to political candidates who voted against universal background checks and were endorsed by the NRA. These PACs contributed to more than twice as many incumbent US Senate candidates who voted against an amendment to expand firearm background checks than those who voted for the amendment. In the US House of Representatives, the pattern of giving was similar. These PACs gave $2.8 million more to candidates who did not sponsor a bill to expand background checks than to those who did. Finally, these physician PACs were more than twice as likely to contribute to and gave almost $1.5 million dollars more to candidates rated A by the NRA.
Author Interviews, Inflammation, JAMA, Kidney Disease, Pain Research, Stanford / 16.02.2019

MedicalResearch.com Interview with: Alan Nelson, MPAS, PhD Division of Primary Care and Population Health, Department of Medicine Stanford University School of Medicine Stanford, California  MedicalResearch.com: What is the background for this study?   Response: The past research literature has provided relatively little information on the appropriate level of concern regarding non-steroidal anti-inflammatory drugs (NSAIDs) and kidney disease risk among younger, apparently healthy patients. Clinicians are generally most concerned about the effects of these medications on the kidneys among patients with existing renal impairment and persons at risk for it, especially older patients. Given that NSAID use appears to be high and rising in the US, we were interested in developing evidence on this topic in a population of working-age adults.
Author Interviews, JAMA, Thyroid, Thyroid Disease / 04.02.2019

MedicalResearch.com Interview with: [caption id="attachment_47320" align="alignleft" width="120"]Joanna Klubo-Gwiezdzinska, M.D., Ph.D., M.H.Sc. Assistant Clinical Investigator/Assistant Professor Metabolic Disease Branch/NIDDK/NIH Bethesda, MD Dr. Klubo-Gwiezdzinska[/caption] Joanna Klubo-Gwiezdzinska, M.D., Ph.D., M.H.Sc. Assistant Clinical Investigator/Assistant Professor Metabolic Disease Branch/NIDDK/NIH Bethesda, MD MedicalResearch.com: What is the background for this study? What are the main findings? Response: People with intermediate- and high-risk differentiated thyroid cancer (DTC) are treated with surgical removal of the thyroid gland and radioactive iodine therapy.  After surgery and initial treatment, the thyroid hormone levothyroxine is used for long-term management not only to replace appropriate physiologic thyroid hormones post-surgery, but also to suppress thyrotropin (TSH) release from the pituitary gland at supraphysiologic doses. The current recommended American Thyroid Association TSH suppression goal in patients with a high-risk differentiated thyroid cancer presenting with distant metastases is less than 0.1mIU/ml, and between 0.1-0.5 mIU/ml for patients with intermediate-risk DTC presenting with local metastases to the neck lymph nodes. This TSH goal is much lower than physiologic TSH level, which ranges between 0.4-4.1 mIU/ml, depending on the measurement method and person’s age. TSH suppression is used because some preclinical evidence suggests that TSH can stimulate growth of cancer cells.  However, several preclinical studies show that thyroid hormones may also stimulate cancer growth. In addition, too much levothyroxine, leading to TSH suppression, may cause side effects such as abnormal heart rhythms and decreased bone mass. In this study, based on a large multicenter database analysis, we found that continuous TSH suppression with levothyroxine was not associated with better progression-free survival and overall survival in patients with either intermediate- and high-risk differentiated thyroid cancer. The patients were followed for an average of 7 years after surgical thyroid cancer removal and radioactive iodine therapy. 
Author Interviews, Hospital Readmissions, JAMA, Nursing / 29.01.2019

MedicalResearch.com Interview with: [caption id="attachment_47212" align="alignleft" width="150"]Marianne Weiss DNSc RN READI study Principal Investigator Professor of Nursing and Wheaton Franciscan Healthcare / Sister Rosalie Klein Professor of Women’s Health Marquette University College of Nursing Milwaukee Wi, 53201-1881 Dr. Weiss[/caption] Marianne Weiss DNSc RN READI study Principal Investigator Professor of Nursing and Wheaton Franciscan Healthcare / Sister Rosalie Klein Professor of Women’s Health Marquette University College of Nursing Milwaukee Wi, 53201-1881 MedicalResearch.com: What is the background for this study? What are the main findings? Response: Our team of researchers has been studying the association of patient readiness for discharge and readmission for several years. We have previously documented that patients who had ‘low readiness’ on our Readiness for Hospital Discharge Scale were more likely to be readmitted. In this study we added structured protocols for discharge readiness assessment and nurse actions to usual discharge care practices to determine the optimal protocol configuration to achieve improved post-discharge utilization outcomes. In our primary analysis that included patients from a broad range of patient diagnoses, we did not find a significant effect on readmission from adding any of the discharge readiness assessment protocols. The patient sample came from Magnet hospitals, known for high quality care, and the average all-cause readmission rates were low (11.3%). In patients discharged from high-readmission units (>11.3%), one of the protocols was effective in reducing the likelihood of readmission. In this protocol, the nurse obtained the patients self-report of discharge readiness to inform the nurse’s discharge readiness assessment and actions in finalizing preparations for discharge. This patient-informed discharge readiness assessment protocol produced a nearly 2 percentage point reduction in readmissions. Not unexpectedly, in lower readmission settings, we did not see a reduction in readmission; not all readmissions are preventable. In the last phase of study, we informed nurses of a cut-off score for ‘low readiness’ and added a prescription for nurse action only in cases of ‘low readiness’; this addition to the protocol added burden to the nurses’ daily work and eliminated the beneficial effects, perhaps because it limited the nurse’s attention to only a subset of patients. 
Author Interviews, Hospital Readmissions, JAMA, Primary Care / 28.01.2019

MedicalResearch.com Interview with: Dr. Dawn Wiest, 7-day pledge after hospital admissionDawn Wiest, PhD Director, Action Research & Evaluation Camden Coalition of Healthcare Providers MedicalResearch.com: What is the background for this study? Response: Understanding the role of care transitions after hospitalization in reducing avoidable readmissions, the Camden Coalition launched the 7-Day Pledge in 2014 in partnership with primary care practices in Camden, NJ to address patient and provider barriers to timely post-discharge primary care follow-up. To evaluate whether our program was associated with lower hospital readmissions, we used all-payer hospital claims data from five regional health systems. We compared readmissions for patients who had a primary care follow-up within seven days with similar patients who had a later or no follow-up using propensity score matching.
Author Interviews, Cancer Research, Gender Differences, JAMA, UCLA / 25.01.2019

MedicalResearch.com Interview with: [caption id="attachment_47094" align="alignleft" width="200"]Dr. Ann Raldow MD MPH Assistant Professor Department of Radiation Oncology David Geffen School of Medicine UCLA Dr. Raldow[/caption] Dr. Ann Raldow MD MPH Assistant Professor Department of Radiation Oncology David Geffen School of Medicine UCLA  MedicalResearch.com: What is the background for this study? What are the main findings? Response: Similar to women in other historically male-dominated fields, female radiation oncologists face unique obstacles in achieving many metrics of career success, including equal salary, research funding, and academic promotion. Our study of industry payments found that female radiation oncologists were less likely than their male colleagues to receive payments from industry and that these payments tended to be of smaller monetary value.
Author Interviews, Health Care Systems, JAMA / 21.01.2019

MedicalResearch.com Interview with: [caption id="attachment_47027" align="alignleft" width="160"]David Shulkin, MD Ninth Secretary, U.S. Department of Veterans Affairs Washington, District Of Columbia Shulkin Solutions LLC Gladwyne, Pennsylvania Dr. Shulkin[/caption] David Shulkin, MD Ninth Secretary, U.S. Department of Veterans Affairs Washington, District Of Columbia Shulkin Solutions LLC Gladwyne, Pennsylvania MedicalResearch.com: What is the background for this study? What are the main findings?  Response: I came to VA in 2015 as Under Secretary for Health, as a result of the 2014 wait time crisis.  At that time, it was determined that in some locations, veterans had been waiting for care for too long and there were allegations that this had resulted in harm to a number of veterans.  I was in the private sector at the time, but was asked by President Obama to come and help improve the situation. Upon my arrival we created systems to determine which veterans were waiting for urgent healthcare and which ones for routine care.  From here, we established same day services for all veterans waiting for urgent care through primary care and behavioral health access points.  This goal was achieved nationwide at the end of 2016.  When I became Secretary in 2017,  we began publishing our wait time data for all to see, so that veterans had accurate information on which to base their choices on and to provide transparency into where we were improving and where we needed to focus our efforts.  In addition, through programmatic and legislative efforts, we expanded our utilization of private sector options so that veterans with clinical needs would be able to get better access to care. This study was meant to determine whether our efforts from 2014 had resulted in improvements to access and in addition how access to care in the VA compared to access in the private sector.   Despite limitations in the data available from the private sector (since others do not publish their actual wait time data similar to VA) we used a data set that we felt had some applicability for these comparisons. We found that for the most part, VA wait times are often shorter than in the private sector,  and that VA wait times had improved since 2014 while the private sectors access had stayed the same. 
Author Interviews, Cancer Research, Cost of Health Care, JAMA / 08.01.2019

MedicalResearch.com Interview with: [caption id="attachment_46845" align="alignleft" width="200"]Kiu Tay-Teo, PhD World Health Organization Geneva, Switzerland Dr. Kiu Tay-Teo[/caption] Kiu Tay-Teo, PhD World Health Organization Geneva, Switzerland MedicalResearch.com: What are the main findings? Response: High costs and high risks of R&D for drugs have been presented to justify high drug prices, especially for cancer drugs. However, it is unclear whether prices are in fact justifiable compared to the overall return on R&D investment. In this paper, we systematically compared incomes from the sales of cancer drugs with the R&D costs. We quantified the incomes generated from the sales of 99 cancer drugs approved by FDA from 1989–2017. This was based on sales figures reported in the originator companies’ annual financial reports, and where necessary, estimates deduced from the reported figures. The sales incomes were net of rebates and discounts, but without accounting for expenses and taxes. For the R&D costs of bringing one new cancer drug to the market, the literature reported a typical costs of between $219 million and $2.9 billion, after accounting for the costs of failed products that were investigated but not marketed and the opportunity costs. For the main analysis, we used a median cost of $794 million, as reported in the literature. To be clear, this analysis did not estimate profit return because we do not have information about the costs and year-to-year variations in costs (i.e. expenses and taxes) specific to cancer drugs.
Author Interviews, Education, JAMA, OBGYNE, Pediatrics, Social Issues / 21.12.2018

MedicalResearch.com Interview with "Pregnancy 1" by operalynn is licensed under CC BY 2.0Josephine Funck Bilsteen, MSc Department of Pediatrics, Hvidovre University Hospital, Hvidovre, Section of Epidemiology, Department of Public Health University of Copenhagen Copenhagen, Denmark MedicalResearch.com: What is the background for this study? What are the main findings?  Response: The background of this study is that there is increasing recognition of the longer-term health and social outcomes associated with preterm birth such as independent living, quality of life, self-perception and socioeconomic achievements. However, much less is known about differences in education and income among adults born at different gestational weeks in the term period. In this study shorter gestational duration, even within the term range, was associated with lower chances of having a high personal income and having completed a secondary or tertiary education at age 28 years. This is the first study to show that adults born at 37 and 38 completed weeks of gestation had slightly lower chances of having a high income and educational level than adults born at 40 completed weeks of gestation. 
Author Interviews, FDA, JAMA, Medical Imaging / 04.12.2018

MedicalResearch.com Interview with: Aldo Badano, Ph.D. Deputy Director, Division of Imaging, Diagnostics, and Software Reliability Office of Science and Engineering Laboratories Center for Devices and Radiological Health Silver Spring, MD 20993 Aldo Badano, Ph.D. Deputy Director, Division of Imaging, Diagnostics, and Software Reliability Office of Science and Engineering Laboratories Center for Devices and Radiological Health Silver Spring, MD 20993  MedicalResearch.com: What is the background for this study? What are the main findings?  Response: Expensive and lengthy clinical trials can delay regulatory evaluation of innovative technologies, affecting patient access to high-quality medical products. Although computational modeling is increasingly being used in product development, it is rarely at the center of regulatory applications. Within this context, the VICTRE project attempted to replicate a previously conducted imaging clinical trial using only computational models. The VICTRE trial involved no human subjects and no clinicians. All trial steps were conducted in silico. The fundamental question the article addresses is whether in silico imaging trials are at a mature development stage to play a significant role in the regulatory evaluation of new medical imaging systems. The VICTRE trial consisted of in silico imaging of 2986 virtual patients comparing digital mammography (DM) and digital breast tomosynthesis (DBT) systems. The improved lesion detection performance favoring DBT for all breast sizes and lesion types was consistent with results from a comparative trial using human patients and radiologists.